BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM

    K Number: K120086 · Decision Apr 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    46
    Registration Numbers
    47
    Same Product Code
    40
    Applicant Total
    1
    Review Days
    104

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    Basic Information

    Device Name
    CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM
    K Number
    K120086
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1280
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cardiosolutions
    Date Received
    January 11, 2012
    Decision Date
    April 24, 2012
    Product Code
    DRA
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRA Catheter, Steerable

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